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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K152563
Device Name Pulse Oximeter (MD300M/MD300K2)
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
NO.9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE,
SHIJINGSHAN DISTRICT
BEIJING,  CN 100041
Applicant Contact LEI CHEN
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
NO.9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE,
SHIJINGSHAN DISTRICT
BEIJING,  CN 100041
Correspondent Contact LEI CHEN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/09/2015
Decision Date 04/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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